Drug product
Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-1132-2018
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 80828
- Status
- Terminated
- Classification
- Class II
- Quantity
- 818 cartons (40,900 tablets)
- Official record key
drug-enforcement:D-1132-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lots: 17717 Exp. 07/2018; 18493 Exp. 01/2019; 19761 Exp. 04/2019
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations